NCT05644171 RESTORES Trial: RESToration Of Rehabilitative Function With Epidural Spinal Stimulation
| NCT ID | NCT05644171 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Neuroscience Institute |
| Condition | Chronic Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2022-12-19 |
| Primary Completion | 2030-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2022-12-19 with a primary completion date of 2030-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Spinal Cord Injury (SCI), being a devastating diagnosis, has little to no recovery which leads to a long-standing of debilitating impairment for affected patients. The NNI Neurosurgery team, together with our collaborators, are expanding our recruitment from our pilot trial named RESTORES: RESToration of Rehabilitative function with Epidural Spinal Stimulation. This study aims to investigate the feasibility of electrical stimulation via a spinal cord stimulator (SCS), which will be implanted into the study subjects, and advanced robotic neurorehabilitation to aid in improving neurological function in patients diagnosed with chronic SCI. An additional 15 patients on top of the 3 ongoing patients, male and female participants, above the age of 21 who have been diagnosed with the condition for more than a year will be recruited for this study over a 2-year period. Rehab sessions will take place pre and post-surgical implant, assessing subject improvements
Eligibility Criteria
⦁ Inclusion Criteria For inclusion in the study, the potential patient has to fulfil all of the following criteria: 1. 21 years old and older 2. Chronic (greater than one year) motor complete (AIS classification A or B) SCI 3. Spinal injury between the levels of Cervical 2 (C2) to Thoracic 12 (T12) 4. Segmental reflexes that remain functional below the level of lesion 5. Able to perform the perioperative rehabilitation program as judged by the research team * Exclusion Criteria Potential patients will be excluded from the trial if they fulfil any of the following criteria: 1. Significant medical co-morbidities that would significantly increase the risk of the operation 2. Severe dysautonomia with systolic blood pressure fluctuation less than 50 or more than 200mmHg on tilt table testing 3. Painful musculoskeletal dysfunction, contractures, unhealed fractures, pressure sores, severe spasticity, and osteoporosis 4. Significant psychological issues or ongoing drug abuse 5. Pregnancy and lactating patients 6. Progressive spinal cord disease
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05644171 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Chronic Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05644171 currently recruiting?
Yes, NCT05644171 is actively recruiting participants. Contact the research team at wan.kai.rui@singhealth.com for enrollment information.
Where is the NCT05644171 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT05644171 clinical trial?
NCT05644171 is sponsored by National Neuroscience Institute. The trial plans to enroll 18 participants.